... FAIRHOPE Ala. Aug. 14 2014 /... In July Express Scripts began sending form letters to more than a hal...In most letters Express Scripts states that it will end coverage in S...Numerous state and federal laws and regulations are aimed at ensuring ...

FAIRHOPE, Ala., Aug. 14, 2014 /PRNewswire/ -- Express Scripts, the nation's largest pharmacy benefit manager, is offering ambiguous and misleading reasons for ending coverage of customized prescription medications for 540,000 individuals in order to conceal financial motives, a Patients and Physicians for Rx Access said Thursday, Aug. 14. The organization is fighting to stop the unprecedented benefit cuts being made by Express Scripts and other pharmacy benefit managers.

"In July Express Scripts began sending form letters to more than a half-million patients nationwide, saying it will stop paying for their compounded medications on September 15," said Jay McEniry, executive director of Patients and Physicians for Rx Access. "Patients are sharing those letters with us. The letters are filled with misleading statements designed to confuse these patients while denying them access to important medications prescribed by their doctor."

In most letters, Express Scripts states that it will end coverage in September because the patient's medication contains at least one ingredient that has not been verified as safe and effective by the federal Food and Drug Administration. However, Express Scripts fails to mention that the FDA verification process is generally reserved for testing mass-produced drugs made by large manufacturers. The FDA process is not applied to compounded prescriptions because pharmacists custom make the medications based on a doctor's order to meet the unique needs of each individual patient.

Numerous state and federal laws and regulations are aimed at ensuring the safety and efficacy of compounded medications. For example, pharmacists are required to purchase ingredients used in compounded medications from FDA-regulated suppliers, who also supply ingredients to many commercial drug manufacturers.

Some Express Scripts patients have received letters that fail to tell them their compounded prescription coverage is ending, instead describing the cutoff as a "clarification" of coverage. Those letters mention nothing of the mid-September cutoff date. Both versions of the letter instruct patients to replace their customized prescriptions with mass-produced, FDA-approved medicines, but warn that Express Scripts may not cover the new medications either.

In presentations regarding these benefit cuts, Express Scripts executives have told other audiences that the company's goal is to save hundreds of millions of dollars annually by ending coverage of essentially all compounded medicines before the end of 2014. When talking to patients, however, Express Scripts attempts to conceal its financial motives with misleading statements, McEniry said.

"By arbitrarily eliminating an entire class of medications, Express Scripts is unfairly limiting physician and patient options," McEniry noted. "Express Scripts is placing the physician in the impossible position of either prescribing a medication that the patient needs but can't afford, or prescribing a less effective treatment because it may be covered by the patient's insurance. Express Scripts is effectively hijacking the physician-patient relationship."

Linda Sauer of Dwight, Ill., one of the 540,000 patients affected by the Express Scripts decision, said she is taking her story to social media to tell others what the company is doing. Sauer has several painful and debilitating conditions that are treated with customized prescription medications.

"Express Scripts is denying me access to medicines that work better than the mass-produced drugs I've tried," Sauer said. "It's not fair to suddenly refuse to pay for medications that patients have relied upon for years in some cases, just to pad the company's bottom line. Express Scripts' decision will cost me hundreds of dollars per month, and I'm just one of many who are affected."

In addition to Express Scripts, other companies that have announced or recently implemented plans to eliminate or severely limit coverage of compounded medicines include United Healthcare/Optum Rx, CVS/Caremark, Catamaran, Harvard Pilgrim and some Blue Cross Blue Shield organizations. The Federal Trade Commission has estimated that 95 percent of all individuals who have a prescription benefit receive their coverage through a pharmacy benefit manager.

The move to eliminate coverage for an entire category of medicines is unprecedented; instead, pharmacy benefit managers typically use numerous mechanisms at their disposal to manage the cost of medications. Furthermore, the latest cuts are being made despite numerous studies that indicate compounded medications meet an important medical need.

Physicians prescribe customized medications to an increasing number of patients for a variety of reasons. Compounded medications are prescribed for patients who are allergic to dyes, glutens and other ingredients found in mass-produced medications. Another major use of compounded medications is to treat patients with persistent pain who need to avoid the side effects of potentially addictive opioid pain medications.

Other patients rely on customized medications to treat the symptoms of cancer and diabetes, to help heal wounds, and to address hormonal imbalances and other conditions that have not responded well to commercially made drugs.

Express Scripts reportedly covers as many as 90 million people; the company says its cutbacks will affect "only 0.6 percent" of its patients, which equals 540,000 individuals. This elimination of benefits effectively impacts all 90 million Express Scripts patients by shutting off access to essential medicines they may need in the future.

About Patients and Physicians for Rx AccessPatients and Physicians for Rx Access is a coalition consisting of individual patients, patient advocacy groups, pharmacists, physicians, pharmacies and healthcare organizations focused on raising awareness about compounded prescription access. The coalition formed to protect patients from the immediate threat from a growing number of pharmacy benefit management firms and insurers who are working quietly to deny coverage for the vast majority of compounded medicines.

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